[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482106":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":68,"collaborators":72,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":20,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":20,"enrollmentInfo":89,"targetDuration":20,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":107,"whyStopped":20,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Iowa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"212-Lead Pentixather","EXPERIMENTAL","Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints.\n\nTreatment is administered in 2 cycles with 6 weeks between the cycles.",[13,14],"Drug: 212-Lead Pentixather","Diagnostic Test: 203-Lead Pentixather SPECT\u002FCT",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DIAGNOSTIC_TEST","203-Lead Pentixather SPECT\u002FCT","Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.",[9],[27],{"name":28,"affiliation":5,"role":29},"Yusuf Menda, MD","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":20,"email":34},"CONTACT","319-356-3214","yusuf-menda@uiowa.edu",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":38},"Kellie Bodeker, Ph.D.","319-384-9425","kellie-bodeker@uiowa.edu",[40],{"facility":41,"status":20,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University of Iowa Health Care","Iowa City","Iowa","52242","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-91.53017,41.66113,{"lat":51,"lon":50},[54,55,58,59,62,64,66],{"name":28,"role":32,"phone":33,"phoneExt":20,"email":34},{"name":56,"role":32,"phone":20,"phoneExt":20,"email":57},"Kristin West, RN, BSN","kristin-gaimari-varner@uiowa.edu",{"name":28,"role":29,"phone":20,"phoneExt":20,"email":20},{"name":60,"role":61,"phone":20,"phoneExt":20,"email":20},"Stephen Graves, PhD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":20,"phoneExt":20,"email":20},"Joseph Dillon, MD",{"name":65,"role":61,"phone":20,"phoneExt":20,"email":20},"David Bushnell, MD",{"name":67,"role":61,"phone":20,"phoneExt":20,"email":20},"Michael Graham, MD, Ph.D.",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Yusuf Menda","Professor and Director, Nuclear Medicine",[73,76,78],{"name":74,"class":75},"National Institutes of Health (NIH)","NIH",{"name":77,"class":75},"National Cancer Institute (NCI)",{"name":79,"class":6},"Holden Comprehensive Cancer Center","100482106","early-phase-1-a-safety-study-of-212pb-pentixather-radioligand-therapy-100482106",false,"NCT05557708","A Safety Study of 212Pb-Pentixather Radioligand Therapy","Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)","Inclusion Criteria:\n\n* ability to provide independent consent\n* adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g\u002FdL; neutrophil count ≥ 1,500 cells\u002Fmm3)\n* adequate kidney function (creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation\n* adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)\n* failed initial therapy or declined further therapy known to confer benefit\n* have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT\u002FCT\n\nExclusion Criteria:\n\n* major surgery within 4 weeks of consent\n* antoher investigational agent within 4 weeks of consent\n* uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* prior solid organ transplant\n* cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)\n* antibody therapy within the 21 days of consent\n* allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent\n* pregnancy\n* breastfeeding\n* refusal to comply with birth control requirements during study","ALL","18 Years",{"count":90,"type":91},20,"ESTIMATED","INTERVENTIONAL",[94],"EARLY_PHASE1","This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.",[97,98,99],"Carcinoid Tumor Lung","Neuroendocrine Tumor of the Lung","Carcinoma, Small-Cell Lung",[101,102,103,104,105,106],"radioligand therapy","pentixather","Lead 203","Lead 212","alpha therapy","dosimetry","NOT_YET_RECRUITING","2025-07-02",{"date":110,"type":111},"2025-07-08","ACTUAL",{"date":113,"type":91},"2026-07-01",{"date":115,"type":91},"2030-06-30",{"name":70,"class":6},1]